Saturday, May 16, 2015

Quote of the day

“These references are not sufficient to support claims and presentations suggesting that Abilify has been demonstrated to modulate dopaminergic and serotonergic activity, or modulate neuronal activity in both hypoactive and hyperactive environments in humans. If you have data to support these claims, please submit them to FDA for review.”
- FDA letter to Otsuka calling for them to “immediately cease” fraudulent advertising of Abilify

So the FDA has at long last gotten around to addressing at least some of this false advertising. The bullshit claims made in promoting Abilify would be funny were it not for the real dangers of the drug, which are also noted in the letter:
The PI also contains several warnings and precautions regarding the risks of cerebrovascular adverse events, including stroke, neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, orthostatic hypotension, leukopenia, neutropenia, and agranulocytosis, seizures and convulsions, potential for cognitive and motor impairment, body temperature regulation, suicide, and dysphagia.
The claims made for this and other psychiatric drugs are nonsense on so many levels. They’re supposed to treat disorders that don’t exist. The notion that the drugs “correct” or “restore” or “modulate” balances of brain chemicals – Abilify is “thought to increase neuronal activity in hypoactive conditions” and “thought to decrease neuronal activity in hyperactive conditions,” which is (thought to be) quite an amazing feat - has been known to be bunk for decades. It’s been so thoroughly debunked, in fact, that psychiatrists have taken to falsely claiming that they never believed or promoted it.

But this makes little difference, as decades of advertising have firmly implanted the notion in the public consciousness. Today, the very mention of “brain chemicals” carries such rhetorical power as a signifier of scientific knowledge that it doesn’t even have to be given content. Shire’s ads for Vyvanse to treat the newly minted bogus “Binge Eating Disorder” assure viewers that “It’s a real medical condition, and while the exact cause is unknown, certain chemicals in the brain may play a role.” Vyvanse is basically an amphetamine, and how amphetamines affect eating is well understood (as are the serious dangers associated with using them for problems related to appetite and weight). “Chemicals in the brain” certainly play a role in binge eating – they play a role in all of our experiences, thoughts, or actions; it’s a perfectly empty statement. Here, the language of “certain chemicals in the brain” is obviously a sleazy rhetorical trick designed to call to mind “chemical imbalances” targeted by a “medication” designed for the purpose.

At this point, their pharmacological claims could be substituted by “magic” with no loss of meaning or information.

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